Curaplex

FDA UDI

Class II (US FDA UDI)

by Pegasus Research Corp.

Identity

Trade Name: CURAPLEX FDA UDI
Generic Name: Heated respiratory humidifier FDA UDI
Device Name: CURAPLEX HEATER CORE FOR 301-P2000, AIR LIFE FIT FDA UDI
Model / Reference: 301-P26000CF FDA UDI
Description: CURAPLEX HEATER CORE FOR 301-P2000, AIR LIFE FIT FDA UDI

Identifiers

Catalog Number: P26020C FDA UDI
Primary DI / UDI-DI: 00612223260026 FDA UDI
510(k) Number: K880473 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Heated respiratory humidifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 4.5 Inch FDA UDI
Outer Diameter — 4 Inch FDA UDI
Weight — 1 Pound FDA UDI

Category: Heated respiratory humidifier

Curaplex by Pegasus Research Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K880473 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Pegasus Research Corp.

Sources (1)

FDA UDI 610afdbe-8f61-4e35-add1-7e6b69ecda64 36 fields · synced May 30, 2026